510(k) K980296

OLDELFT DIGIDELCA by Oldelft Corp. of America — Product Code KPR

K980296 is an FDA 510(k) premarket notification submitted by Oldelft Corp. of America for the device "OLDELFT DIGIDELCA". The FDA issued a decision of Substantially Equivalent on April 17, 1998. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Oldelft Corp. of America has at least 8 other 510(k) clearances on record.